Rationale and Analysis of the Use of ETDNO in the Treatment of PIPJ Flexion Contracture:

Joint Deformities, Acquired Clinical Trial

Official title:

Rationale for the Use of Elastic Tension Digital Neoprene Orthoses in the Treatment of Proximal Interphalangeal Joint Flexion Contracture: Long Term Results

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05465603
• Other study ID #: 001
• Status: Completed
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: December 14, 2022

Study information

• Verified date: January 2023
• Source: Hand Therapy Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Introduction: Flexion contracture is one of the most frequent complications in finger trauma. The use of orthoses to obtain the best total end range time (TERT) is the most popular method to treat this pathology . Until now, no orthosis applied for longer than 3 weeks had been able to achieve TERT longer than 12 hours.

Purpose of the study: To assess whether the elastic tension digital neoprene orthosis (ETDNO), using a serial dynamic program, can achieve a better result in ROM and TERT than other orthoses described in the literature.

Methods: analysis of outcomes in a sample of 30 patients with PIP joint flexion contracture treated with the ETDNO and serial dynamic program.

Description:

In this study the researcher will compare the efect of daily TERT treatment on the proximal interphalangeal joint contracture using an ETDNO. The investigator will treat two different groups one with a dose of from 11 to 13 hours of the ETDNO while the other one is treated with a dose of from 20 to 22 hours of daily TERT with the same device. This treatment will last three weeks and will be evalauted the first day, the he first week and the third week. At the end of the study the researcher will quantify the improvement on both groups to know which dailyTERT dose is the best option.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 14, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• PIP flexion contracture

Exclusion Criteria:

• more than 6 month of contracture and more than 45º of flexion contracture

Related Conditions & MeSH terms

• Contracture
• Joint Deformities, Acquired

Intervention

Device:
• ETDNO (Elastic Tension digital neoprene orthosis)
A bespoke orthosis created from neoprene.

Locations

Country	Name	City	State
Spain	Hand Therapy Barcelona	Barcelona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Vicenç Punsola Izard

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extension improvement	The degree of extension of the PIP at the end of the treatment compared with the beginning	3 weeks